Intended Use; User Profile - GCE E-MINISTAR Notice D'utilisation

ENGLISH
INSTRUCTION FOR USE: E MINISTAR
1. FOREWORD
The product complies with essential requirements of 93/42/EEC Medical Device Directive and
2010/35 EU Transportable Pressure Equipment Directive.
The valve is designed according to EN ISO 10524-3 standard.
EN
TERM
E MINISTAR
EMM O2
X.Y.ZZZ
LCD

2. INTENDED USE

E-Ministar Combination Valves equipped with E-Indicator Display and guard are designed to be
fi tted to gas cylinders used for medical gases. These combination valves together with a gas
cylinder form gas packages used either as gas supply point for medical devices (anaesthetic
devices, ventilating devices, incubators etc.) or for direct gas supply to a patient's breathing
mask or cannula.
GCE Combination Valves are intended to be used with the following medical gases:
• Oxygen
• Nitrous oxide
• Air for breathing
• Helium
• Carbon dioxide
• Xenon
• Specifi ed mixtures of the gases listed
2.1. PATIENT PROFILE
Regulator valve get gas fl ow from 0 to 15 liter per minutes. Information about specifi cation fl ow
rate you can fi nd in the appendix No. 1 of Instruction for use. Flow rate is listed in the Appendix
No. 1 of instruction of use in the table on the position C and this Appendix is supplied to every
product. The saturation of gas must be estimated by doctor or anesteziologic nurse. They have
necessary education, where they must know health status of patient and get him important gas
support. Health status - used, when the patient will be need to support of medical gases for
supporting breathing and decision about treatment is on the side doctor or health personal.
Health personal – nurse, rescuer, paramedic, keeper or person with medical education.

2.2. USER PROFILE

Use in a hospital or in an ambulance
• Education: personal with medical education
• Knowledge: training from person with medical education ability to read, study and knowledge
of user manual
• Training is provided according to local law in individuals countries.
MEANING
Pressure regulators integrated with cylinder valve equipped with
the EMM O2-X.Y.ZZZ and guard.
Electronic Medical Module for Oxygen connected to the E-Ministar
sensor providing a function of gas content indicator.
Further only called E-Indicator Display.
Numbering X.Y.ZZZ defi nes the hardware and software version and inlet
pressure for which the E-Indicator Display shall be used.
Liquid crystal display
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